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Gajanan Jalinder Chavan*, Atul Pandurang Kumbhar and Nikhil Prabhakar Patil


The aim of the present study was to establish bilayer tablet formulation containing Metformin hydrochloride as sustained release layer and Glimepiride as conventional immediate release layer. Layer containing Metformin hydrochloride 1 g exhibits sustained release, were prepared by wet granulation method using hydroxypropylmethyl cellulose K15 M and K4 M as matrix forming polymers and Poly-vinyl-pyrrolidone K-30 as binder along with isopropyl-alcohol as binding liquid. Immediate release layer containing Glimepiride were prepared by wet granulation method using poly-vinyl-pyrrolidone as binder with water. Crosscarmellose sodium used as intra granular as well as extragranular superdisintegrant in immediate release layer. Colour erythrosine lake was used to differentiate layers and to enhance elegance of the tablets. The prepared granules were evaluated for bulk density, tapped density, compressibility index, Hausner’s ratio, and angle of repose, the concentrations of on mechanical additives i.e. glidants and lubricants are efficient enough to keep the values of these parameters within very good to excellent level as per USP. In vitro release studies were carried out by USP type 1 apparatus (Basket) for SR layer and USP type 2 apparatus (Paddle) for IR layer. The results showed that hydroxypropylmethyl cellulose K15M in sustained layer can control the release of drug. The in vitro release profile of drug from sustained release layer diffusion was the dominant mechanism of drug release. The formulation (GF5) having immediate release layer produces immediate effect 97 + 0.24% within 15 minutes. The formulation (MF8) having Sustained release layer produces sustained release effect 98 + 0.41 % up to 12 hours.

Keywords: Bilayer tablet, Glimepiride, Metformin HCl, Sustained Release.

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